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Sienna Biopharmaceuticals, Inc. (NASDAQ:SNNA) today announced that the first patient has been dosed in the Company’s Phase 2b clinical trial of topical product candidate SNA-120 (pegcantratinib) in the treatment of pruritus, or itch, associated with psoriasis and in the treatment of psoriasis itself. SNA-120 is designed to selectively inhibit tropomyosin receptor kinase A, or TrkA, the high affinity receptor for nerve growth factor, or NGF, a known mediator of itch and neurogenic inflammation associated with psoriasis. This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy, safety and tolerability of SNA-120 compared to vehicle in approximately 190 patients with at least moderate pruritus and mild-to-moderate psoriasis.

“We are excited to announce the start of this trial for our lead product candidate, SNA-120, from our Topical by Design™ platform,” said Frederick C. Beddingfield III, M.D., Ph.D., President and Chief Executive Officer of Sienna. “The vast majority of psoriasis patients report that they suffer from itch, and reducing the itch has been shown to be as important to patients as improving the visible plaques. Additionally, most psoriasis patients with mild-to-moderate disease typically resort to decades-old therapies that are only marginally effective or unsuitable for chronic administration. We believe that SNA-120 has the potential to topically deliver effective relief to patients suffering from the distress of itch and improve the underlying psoriasis with a favorable tolerability profile. We look forward to the data, which we expect to report in the first half of 2019.”

“Sienna is taking a truly unique approach to the treatment of the signs and symptoms of psoriasis by targeting neurogenic inflammation topically via the NGF-TrkA signaling pathway,” said Paul F. Lizzul, M.D., Ph.D., Chief Medical Officer of Sienna. “SNA-120 inhibits the TrkA receptor, reducing the neurogenic inflammation and the signaling of itch sensation by peripheral nerves. Inhibition of TrkA also can mitigate the hyperproliferation of keratinocytes, a hallmark of psoriatic plaques. Our goal with this Phase 2b trial is to evaluate SNA-120 in a refined target patient population and to further validate the NGF-TrkA pathway in the treatment of both pruritus associated with psoriasis and the underlying psoriasis itself.”

Patients will be randomized in a 1:1:1 ratio to one of two concentrations of SNA-120 (0.05% or 0.5%) or vehicle and treated twice daily for 12 weeks. The primary endpoint is the change in pruritus on the 11-point itch Numeric Rating Scale from baseline to week 8. Secondary endpoints include the proportion of patients achieving improvement in the five-point Investigator Global Assessment from baseline to week 12 and the proportion of patients achieving PASI-50, or at least a 50% improvement in the Psoriasis Area and Severity Index, from baseline to week 12. The trial will be conducted at approximately 20 centers in the United States.

With the commencement of this Phase 2b trial, Sienna will make a $5 million milestone payment to the former shareholders of Creabilis plc, in shares of Sienna common stock, subject to certain offsets, based on the volume-weighted average price of the stock over the 20-day trading period preceding the commencement of the trial.